Background
The scorecard was included in a couple of articles earlier this year. As promised, I will update it from time to time. Feedback and further news is, as always, very welcome.
Why track the global patent dispute between Ranbaxy and Pfizer (Warner Lambert) over the world’s biggest selling drug – Lipitor? This is a no-brainer for those in the pharmaceutical industry, particularly in light of the associated life cycle management moves by Pfizer.
For those who aren’t in the pharmaceutical industry, among many things, this is a relatively rare opportunity to monitor how the courts of a large number of countries deal with patents with similar specifications and claims.
Since the last update:
Ranbaxy launched generic Atorvastatin (Lipitor) in Malaysia and received favorable rulings in Spain (invalidity of the Basic patent).
Pfizer has obtained favorable rulings in Austria (infringement of Basic patent), the European Patent Office (validity of the Basic patent) and the USA (validity & infringement of the Enantiomer patent). Pfizer also announced plans to seek correction of the technical defect which invalidated the Basic Patent in the USA (this would render Ranbaxy’s earlier win as meaningless).
Comment
Given the size of the market for Lipitor, even in small countries, Ranbaxy will only need to launch in a few to regain its litigation costs. However, without knowing all of the facts, it seems that a more targeted strategy would have brought much better returns.
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My two most recent articles were:
The scorecard
|
Country |
Date |
Comment |
|
Austria |
Apr 06
Oct 06 |
A five Judge panel of Austria’s Supreme Patent and Trademark Board held relevant claims of the enantiomer patent (AT 207896) to be anticipated and obvious in light of WO 89/07598 and US 4,681,893 respectively. Basic patent in force until ~2011. Austrian Patent Office rules that Ranbaxy’s product would infringe the Basic patent. |
|
Australia |
Aug 2005 |
Ranbaxy commences proceedings in Australian Federal Court. (Trial in October 2006.) |
|
Ecuador |
Dec 2005 |
Andean Court of Justice dismisses invalidity case against Lipitor patents. The decision stops any further validity challenges in Ecuador, Peru and Venezuela. |
|
European Patent Office |
Oct 2006 |
European Patent Office issues an advisory opinion upholding validity of the Basic patent. (Decision in response to request from Madrid Mercantile Court No. 4.) |
|
Finland |
Feb 2006 |
Preliminary injunction granted against Ranbaxy (pending final outcome of trial). |
|
Malaysia |
Sep 2006 |
Ranbaxy launches first generic atorvastatin (Lipitor) in Malaysia. |
|
Netherlands |
Sep 2006 |
Three Judge panel of the District Court of The Hague in the Netherlands holds the Basic patent infringed by the proposed Ranbaxy product. Enantiomer patent held invalid. Expected launch date – November 2011. |
|
Norway |
Nov 2005
Aug 2006 |
The Oslo City Court holds that of the four patents litigated, one is infringed (claiming a synthetic intermediate), one is not infringed (claiming a synthetic process), and the other two are not ruled on. Ranbaxy files an appeal. The Oslo City Court holds that two process patents (covering intermediate compounds) not infringed Pfizer indicates intention to appeal. |
|
Peru |
Dec 2005 |
Ranbaxy held to infringe enantiomer patent and enjoined from marketing. |
|
Romania |
Dec 2005 |
Pfizer prevails in court proceedings. |
|
Spain |
Dec 2005
Sep 2006 Oct 2006 |
Madrid Court of First Instance finds enantiomer patent valid and enforceable. (Other challenges pending.) Barcelona Mercantile Court No. 2 finds claims 1 to 3 of the Basic patent invalid in two separate decisions (Lek Pharmaceuticals v. Warner Lambert Co. and Laboratorios Cinfa et al. v. Warner Lambert). Madrid Court of Appeal rejects appeal in relation to enantiomer patent. At the request of Barcelona Mercantile Court No. 4, the European Patent Office provides an advisory opinion holding the Basic patent valid. Ranbaxy issues statement to investors referring to the earlier Barcelona Mercantile Court No. 2 decisions and stating that the European Patent Office opinion is not legally binding. |
|
United Kingdom |
Jun 2006 |
Court of Appeal denies declaration of non-infringement but invalidates the enantiomer patent. Click here for a case summary. Basic patent still in force until 2011. |
|
United States |
Aug 2006
Oct 2006 |
Court of Appeal for the Federal Circuit finds Enantiomer patent valid and infringed, but base patent invalid (based on 35 U.S.C. 112 ¶ 4). Click here for a case summary. Court of Appeal for the Federal Circuit denies Ranbaxy’s petition for rehearing. Pfizer announces intention to seek correction of the technical defect which invalidated the based patent. |
The Basic Patent
Example family members:
CA 1268768; EP 247,633; JP 2019432; US 4681893
Example claim 1 (from the EP):
1. A compound of structural formula I EMI28.1 wherein X is -CH2-, -CH2CH2-, -CH2CH2CH2- or -CH2CH(CH3)-;
R1 is 1-naphthyl; 2-naphthyl; cyclohexyl; norbornenyl; 2-, 3-, or 4-pyridinyl; phenyl, phenyl substituted with fluorine, chlorine, bromine, hydroxyl; trifluoromethyl; alkyl of from one to four carbon atoms, alkoxy of from one to four carbon atoms, or alkanoyloxy of from two to eight carbon atoms:
either of R2 or R3 is -CONR5R6
where R5 and R6 are independently hydrogen; alkyl of from one to six carbon atoms; 2-, 3-, or 4-pyridinyl; phenyl; phenyl substituted with fluorine, chlorine, bromine, cyano, trifluoromethyl, or carboalkoxy of from three to eight carbon atoms;
and the other of R2 or R3 is hydrogen; alkyl of from one to six carbon atoms; cyclopropyl; cyclobutyl, cyclopentyl, cyclohexyl; phenyl; or phenyl substituted with fluorine, chlorine, bromine, hydroxyl; trifluoromethyl; alkyl of from one to four carbon atoms, alkoxy of from one to four carbon atoms, or alkanoyloxy of from two to eight carbon atoms;
R4 is alkyl of from one to six carbon atoms; cyclopropyl; cyclobutyl; cyclopentyl; cyclohexyl; or trifluoromethyl;
or a hydroxy acid or pharmaceutically acceptable salts thereof, derived from the opening of the lactone ring of the compounds of structural formula I above.
The Enantiomer Patent
Example family members:
CA 2021546, EP 409,281, JP3506336, US 5273995,
Example claim 1 (from the EP):
[R-(R*,R*)]-2-(4-fluorophenyl)- beta , delta -dihydroxy-5-((1-methylethyl)-3-phenyl-4-[(phenylamino)-carbonyl]-1H-pyrrole-1-heptanoic acid or (2R-trans)-5-(4-fluorophenyl)-2-(1-methylethyl-N,4-diphenyl-1-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1H-p yrrole-3-carboxamide; and pharmaceutically acceptable salts thereof.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
